A recent article published by MedTech, “Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern,” quotes a Crowell client alert and Crowell attorney, Robbie Jost, on this development. According to the client alert, “To the extent the FDA considers the SNOO a medical device based on its intended impact on infant sleep position, many
On March 30, 2023, the FDA authorized marketing of Happiest Baby’s SNOO Smart Sleeper, an over-the-counter infant sleep system intended to keep infants on their back throughout sleep. This marks the first time we are aware of that the FDA has given de novo marketing authorization to a product designed to keep sleeping babies positioned on their backs,[1] and signals a potential expansion of what the FDA considers to be a “medical device” within its regulatory purview.